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    K Number
    K172284
    Device Name
    NAPA LP-15 Airway Pressure Monitor
    Manufacturer
    DRW Medical, LLC
    Date Cleared
    2018-02-09

    (196 days)

    Product Code
    CAP
    Regulation Number
    868.2600
    Why did this record match?
    Applicant Name (Manufacturer) :

    DRW Medical, LLC

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The NAPA LP-15 Airway Pressure Monitor is intended to measure and monitor airway pressure for neonatal patients being treated with positive pressure therapy, including neonatal Continuous Positive Airway Pressure (CPAP) devices (e.g. Bubble CPAP). The device provides audible and visual alarms when the airway pressure falls outside of the user selected high and low alarm limits. The device is intended to be pole mounted for stationary use in hospitals only. For professional use only.
    Device Description
    The NAPA LP-15 Airway Pressure Monitor is a compact mains operated monitoring device that continuously monitors and displays the neonatal patient's average airway treatment pressure during neonatal CPAP therapy (e.g. Bubble CPAP) and provides high and low alarms for pressures that exceed set limits.
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